Feasibility of Suprapubic Transvesical Endoscopic Prostatectomy

NCT ID: NCT07327424

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2027-06-01

Brief Summary

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In patients with penile prosthesis, any transurethral procedure could place the implant at risk. The use of long or extra-long resectoscope can be of some assistance; however, these are not available in many institutions. So suprapubic transvesical endoscopic prostatectomy is newly developed to bypass the anterior urethra. Thus, the aim of this study is to determine safety and efficacy of Suprapubic Transvesical endoscopic prostatectomy.

Detailed Description

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Conditions

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Prostate

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Suprapubic Transvesical endoscopic prostatectomy

Group Type EXPERIMENTAL

Suprapubic transvesical endoscopic prostatectomy

Intervention Type OTHER

Cysto-uretheroscopy will be done to evaluate the urethera , detect any bladder pathology and to visualise steps of insertion of laparoscopic port. The patient will be in supine position, and the surgeon will stand beside the patient .The bladder is filled with normal saline until it is completely full . Using Ultrasound A 18 G puncture needle is inserted 4 cm above the upper margin of the symphysis pubis to gain access to the bladder. then track is formed through single step dilation using a 30 Fr amplatz dilator and 10 mm laparoscopic port over it. Before starting the procedure, the ureteral orifices must be identified.

Interventions

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Suprapubic transvesical endoscopic prostatectomy

Cysto-uretheroscopy will be done to evaluate the urethera , detect any bladder pathology and to visualise steps of insertion of laparoscopic port. The patient will be in supine position, and the surgeon will stand beside the patient .The bladder is filled with normal saline until it is completely full . Using Ultrasound A 18 G puncture needle is inserted 4 cm above the upper margin of the symphysis pubis to gain access to the bladder. then track is formed through single step dilation using a 30 Fr amplatz dilator and 10 mm laparoscopic port over it. Before starting the procedure, the ureteral orifices must be identified.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male patients with moderate to severe lower urinary tract symptoms ( IPSS score ≥ 8 ) indicated for surgical intervention with prostate size less than 120 cc.

Exclusion Criteria

* History of previous pelvic surgery, urothelial cancer, kidney transplantation, uncontrolled coagulopathy, and significant central fat accumulation that could potentially increase the risk during transvesical access(body mass index not exceeding 27 kg/m2)
Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Abdelbary, MD

Ahmed Abdelbary

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni-Suef university

Banī Suwayf, , Egypt

Site Status

Countries

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Egypt

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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FMBSUREC/01072025/Mohamed

Identifier Type: -

Identifier Source: org_study_id

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